Halotestin

WARNINGS

Hypercalcemia may occur in immobilized patients and in patients with breast cancer. If this occurs, the drug should be discontinued.

Prolonged use of high doses of androgens (principally the 17-α alkyl-androgens)
has been associated with development of hepatic adenomas, hepatocellular carcinoma,
and peliosis hepatis—all potentially life-threatening complications.

Cholestatic hepatitis and jaundice may occur with 17-α-alkyl-androgens. Should this occur, the drug should be discontinued. This is reversible with discontinuation of the drug.

Geriatric patients treated with androgens may be at an increased risk of developing prostatic hypertrophy and prostatic carcinoma although conclusive evidence to support this concept is lacking.

Androgen therapy should be used cautiously in males with delayed puberty. Androgens can accelerate bone maturation without producing compensatory gain in linear growth. The effect on bone maturation should be monitored by assessing bone age of the wrist and hand every six months.

This drug has not been shown to be safe and effective for the enhancement of athletic performance. Because of the potential risk of serious adverse health effects, this drug should not be used for such purpose.

PRECAUTIONS

General

Women should be observed for signs of virilization which is usual following androgen use at high doses. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. A decision may be made by the patient and the physician that some virilization will be tolerated during treatment for breast carcinoma.

Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have a aspirin hypersensitivity.

Laboratory tests

Women with disseminated breast carcinoma should have frequent determination
of urine and serum calcium levels during the course of androgen therapy (See
WARNINGS).

Because of the hepatotoxicity associated with the use of 17-alpha-alkylated androgens, liver function tests should be obtained periodically.

Periodic (every six months) X-ray examinations of bone age should be made during treatment of prepubertal males to determine the rate of bone maturation and the effects of androgen therapy on the epiphyseal centers.

Carcinogenesis, mutagenesis, impairment of fertility

Animal data: Testosterone has been tested by subcutaneous injection
and implantation in mice and rats. The implant induced cervical-uterine tumors
in mice, which metastasized in some cases. There is suggestive evidence that
injection of testosterone into some strains of female mice increases their susceptibility
to hepatoma. Testosterone is also known to increase the number of tumors and
decrease the degree of differentiation of chemically-induced carcinomas of the
liver in rats.

Human data: There are rare reports of hepatocellular carcinoma in patients
receiving long-term therapy with androgens in high doses. Withdrawal of the
drugs did not lead to regression of the tumors in all cases. Geriatric patients
treated with androgens may be at an increased risk of developing prostatic hypertrophy
and prostatic carcinoma although conclusive evidence to support this concept
is lacking.

This compound has not been tested for mutagenic potential. However, as noted above, carcinogenic effects have been attributed to treatment with androgenic hormones. The potential carcinogenic effects likely occur through a hormonal mechanism rather than by a direct chemical interaction mechanism.

Impairment of fertility was not tested directly in animal species. However, as noted below under Adverse Reactions, oligospermia in males and amenorrhea in females are potential adverse effects of treatment with HALOTESTIN (fluoxymesterone) Tablets. Therefore, impairment of fertility is a possible outcome of treatment with HALOTESTIN (fluoxymesterone) .

Pregnancy

Nursing mothers

HALOTESTIN (fluoxymesterone) is not recommended for use in nursing mothers.

Pediatric use

Androgen therapy should be used very cautiously in children and only by specialists
aware of the adverse effects on bone maturation. Skeletal maturation must be
monitored every six months by an X-ray of the hand and wrist (See WARNINGS).

Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.